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Catheter, Peritoneal, Long-Term Indwelling

FDA product code FJS · Class 2 · Gastroenterology, Urology

286
Registered devices
2,355
Adverse events
8
Recalls
48
510(k) clearances

Devices with this code

I-SERIES PD Catheter — Medical Components, Inc.I-SERIES PD Catheter — Medical Components, Inc.Argyle — Mozarc Medical US LLCPeritoneal Dialysis Catheter — Medionics International IncArgyle — Mozarc Medical US LLCFlex-Neck® — Merit Medical Systems, Inc.Flex-Neck® — Merit Medical Systems, Inc.I-SERIES PD CATHETER — Medical Components, Inc.VETA Peritoneal Dialysis Catheter — PFM MEDICAL INCORPORATEDArgyle — Mozarc Medical US LLCI-SERIES PD Catheter — Medical Components, Inc.I-SERIES PD Catheter — Medical Components, Inc.Ritus — Mozarc Medical US LLCFlex-Neck® — Merit Medical Systems, Inc.Argyle — Mozarc Medical US LLCArgyle — Mozarc Medical US LLC"X" SERIES PD CATHETER"X" SERIES PD CATHETER — Medical Components, Inc.Peritoneal Dialysis Catheter — Medionics International IncRitus — Mozarc Medical US LLCV-SERIES PD Catheter — Medical Components, Inc.Flex-Neck® — Merit Medical Systems, Inc."X" SERIES PD CATHETER"X" SERIES PD CATHETER — Medical Components, Inc.PERITONEAL CATHETER — Medical Components, Inc.Flex-Neck® — Merit Medical Systems, Inc.

Recent recalls

DateFirmReason
2023-02-15Merit Medical Systems, Inc.Product that was built for design verification testing was inadvertently distributed to customers.
2017-12-20Merit Medical Systems, Inc.Mix-up between adult and pediatrics PD catheter.
2017-09-20Merit Medical Systems, Inc.2 Cuff catheters were incorrectly configured and labeled as 1 Cuff product.
2014-10-20Pfm Medical IncPFM Medical is recalling catheters and other medical devices because they may exceed USP limits for bacterial endotoxin.
2011-05-21Bard Access SystemsLabeling for drainage kit contained incomplete information.
2011-05-21Bard Access SystemsLabeling for drainage kit contained incomplete information.
2011-05-21Bard Access SystemsLabeling for drainage kit contained incomplete information.
2011-05-21Bard Access SystemsLabeling for drainage kit contained incomplete information.

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Sourced from public U.S. FDA data. Informational only — not medical or regulatory advice. Not affiliated with the FDA.